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ODAC Backs Random Sample Audits Of Progression Events

 
• By Sue Sutter

FDA’s Oncologic Drugs Advisory Committee supports easing the current requirement for blinded, independent central review of 100% of patient scans in studies using progression-free survival as the primary endpoint. However, committee members say FDA needs the flexibility to require full case audits in certain circumstances, depending upon tumor type and study size.

Independent review of study investigators’ progression assessments in only a subgroup of patients is a feasible strategy for oncology trials, but may not be appropriate in all cases, FDA’s Oncologic Drugs Advisory Committee said July 24.

While ODAC members endorsed the concept of auditing only a random subgroup of patients’ scans, they said 100% review may still be necessary for small studies and trials in which...

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